AstraZeneca PLC AZN announced that the FDA has granted a Fast Track designation to its SGLT2 inhibitor Farxiga (dapagliflozin) for reducing the risk of cardiovascular (CV) death or worsening of heart failure in heart failure patients.
The blockbuster drug, approved to treat type II diabetes (T2D), is being evaluated in two phase III studies, namely DAPA-HF and DELIVER to see its effect in adults suffering heart failure with reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF), respectively.
The FDA provides a Fast Track designation to help development and faster review of drugs, which treat serious and unmet medical conditions.
Last month, the FDA granted a Fast Track designation to Farxiga for chronic kidney disease (CKD). The drug is being evaluated in the phase III DAPA-CKD study to see its effect on renal outcomes and CV mortality in patients suffering CKD with or without type-2 diabetes (T2D).
All these studies are part of AstraZeneca's DapaCare clinical program to explore the CV, metabolic and renal profile of Farxiga in T2D patients. Farxiga is also being developed to treat patients with heart failure (HFrEF and HFpEF) in DETERMINE study.
Shares of AstraZeneca have rallied 12.6% so far this year against the industry’s decline of 1.9%.
We remind investors that last month, AstraZeneca released positive results from the DAPA-HF study on Farxiga. The study showed that Farxiga met the primary composite endpoint with a statistically-significant and clinically-meaningful reduction in CV death or the worsening of heart failure compared to placebo. The study was conducted in patients with HFrEF who are on standard of care treatment including those with and without T2D.
Also, in the same month, the European Commission approved a label expansion for Farxiga to include positive CV outcomes and renal data from the phase III DECLARE-TIMI 58 study on adults with T2D. A similar filing is under review in the United States. The DECLARE study is also part of the extensive DapaCare clinical program.
Farxiga/Forxiga, a key top-line driver of AstraZeneca, generated sales of $726 million in the first half of 2019, representing 19% growth at constant exchange rates. Farxiga enjoys global leadership with voluminous market share.
Other SGLT2 inhibitors available in the market are Johnson & Johnson’s JNJ Invokana and Lilly’s LLY Jardiance, Synjardy (a fixed dose combination of Jardiance and metformin) and Glyxambi (a fixed dose combination of Jardiance and Tradjenta).
Zacks Rank & Key Pick
AstraZeneca currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the large cap pharma sector is Bristol-Myers Squibb Company BMY, which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Bristol-Myers’ earnings estimates have moved 2.9% north for 2019 and 21.5% for 2020 over the past 60 days.
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